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[实用随机对照试验作为评估医疗技术有效性的数据来源]

[Pragmatic randomized controlled trials as a source of data in the assessment of effectiveness of medical technology].

作者信息

Kaczyński Lukasz, Solnica Bogdan

机构信息

Zakład Diagnostyki Katedry Biochemii Klinicznej, Uniwersytet Jagielloński, Collegium Medicum.

出版信息

Przegl Lek. 2012;69(9):703-7.

Abstract

Acquisition of scientific data needed to make rational decisions about health policy has became an important tool in determining the validity of the financing methods of treatment from public funds under the health technology assessment (HTA). The primary source of scientific evidence for health technology assessment are randomized controlled trials (RCTs, explanatory trials evaluating the efficacy), because of their features reducing methodological bias (e.g. randomization or blindness). These features may become a disadvantage, which seriously reduces the possibility of transfer of the results and conclusions to the level of routine practice. In this situation an important role begin to play studies that provide data on effectiveness-observational studies, registries and pragmatic randomized controlled trials (pRCTs).

摘要

获取用于对卫生政策做出合理决策所需的科学数据,已成为在卫生技术评估(HTA)中确定公共资金用于治疗的融资方法有效性的重要工具。卫生技术评估的科学证据的主要来源是随机对照试验(RCT,评估疗效的解释性试验),因为其具有减少方法学偏倚的特征(例如随机化或盲法)。这些特征可能成为一个劣势,严重降低了将结果和结论推广到常规实践层面的可能性。在这种情况下,提供有效性数据的研究——观察性研究、登记处和实用性随机对照试验(pRCT)开始发挥重要作用。

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